Clinical trial · Interventional
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
NCT06903377CI-TRIAL-00100126recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gecacitinib Hydrochloride Tablets | Drug | — | UNRESOLVED |
| ZG005 for Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part1-Group A
- description
- ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
- interventionNames
- Biological: ZG005 for Injection
- Drug: Gecacitinib Hydrochloride Tablets
- type
- EXPERIMENTAL
- label
- Part1-Group B
- description
- ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid
- interventionNames
- Biological: ZG005 for Injection
- Drug: Gecacitinib Hydrochloride Tablets
Primary outcomes (1)
- measure
- Adverse Event (AE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Fully understand this study and voluntarily sign the ICF. * Age 18-75 years, no gender restriction. * Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy. Exclusion Criteria: * Medical history, CT scan, or MRI indicates the presence of CNS metastases. * Other malignancies within 5 years. * Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.